Avinash Kumar

About Avinash Kumar

I am a competent and versatile professional, having vast 10 years of experience in Global…

Experience

1. Safety Aggregate Report Specilaist

   IQVIA

   Jul 2024 — Present · Bengaluru, IN

   Authored aggregate periodic safety data reports including Development Safety Update Report (DSUR), Periodic Benefit Risk Assessment Reports (PBRERs) and Addendum to clinical Overview Reports.• Managing PBRER and DSUR writers for strategic decision and execution of project till end of the project.• Author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.• Any ad-hoc reports for the assigned products - small to high complexity reports including planning, conducting planning meeting and coordinating for execution. • Perform quality review of the safety documents within established timelines with adherence to applicable guidelines, templates, and process. • Act as Molecule Lead for assigned products. Set-up, implement, organize (including documentation) and lead internal safety management team meetings. Set-up and update products\' signaling strategies, as approved by the customer’s Safety Strategy Lead. • Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterization of risks, as approved by the customer’s Safety Strategy Lead. Responsible for full documentation and tracking of signals.•Conduct/Lead ongoing literature safety surveillance for marketed and investigational products, including evaluation of events of special interests as well as aggregate data review.• Setting, discussing and meeting expectations of the document during kick off and subsequent meetings.